Skip to content

The Effect of N-acetylcysteine on Oxidative Stress Status and Iron Overload in Thalassemia Major

The Effect of N-acetylcysteine on Oxidative Stress Status and Iron Overload in Thalassemia Major

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04260516
Enrollment
100
Registered
2020-02-07
Start date
2019-06-03
Completion date
2019-12-30
Last updated
2020-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thalassemia Major

Brief summary

The effect of N-acetylcysteine as antioxidant and its effect on pretransfusion hemoglobin and iron overload in patients with thalassemia were compared to patients who didn't receive n-acetylcysteine after 3 months of study duration

Detailed description

N-acetylcysteine( NAC) is a widely used mucolytic drug and several studies had reported its efficacy as anti oxidant. Patients with thalassemia major are at great risk for oxidative stress due to excess of b-globin chains and iron overload. In this study the investigators compared the effect of NAC on oxidative status , pretransfusion hemoglobin levels and iron overload in thalassemia patients before and after treatment with NAC for 3 months and with that of patients who served as controls.

Interventions

DRUGN-acetyl cysteine

Mucolytic and antioxidant drug

Sponsors

Beni-Suef University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Two groups are followed up for study parameters for 3 months one group is the intervention group and the other is the control group

Eligibility

Sex/Gender
ALL
Age
3 Years to 14 Years
Healthy volunteers
No

Inclusion criteria

* Thalassemia major children on regular blood transfusion and iron chelation therapy

Exclusion criteria

* Renal or hepatic impairments * Complicated thalassemia major * Non adherence to therapy or follow up visits * Change in the iron chelation dose within 3 months before enrollment or during study period

Design outcomes

Primary

MeasureTime frameDescription
Oxidative stress index (pg/mmol)3 monthsOxidative stress index is calculated as the ratio of total oxidative status (pg/dl) to total anti oxidative capacity (mmol/dl)
Serum ferritin level ( mg/dl)3 months

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026